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64000-00137 Rev 1
6. WARNINGS AND PRECAUTIONS
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Warnings
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The gammaCore Sapphire CV has neither been cleared nor approved for acute use at home
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or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are
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experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom
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approved drug therapies are not tolerated or provide insufficient symptom relief as assessed
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by their healthcare provider, by using non-invasive vagus nerve stimulation (nVNS) on either
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side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic.
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The safety and efficacy of gammaCore Sapphire CV has not been formally evaluated in any
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patients with COVID-19
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The gammaCore Sapphire CV is contraindicated for:
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Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or
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any implanted electronic device
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o
Patients with a metallic device, such as a stent, bone plate, or bone screw, implanted at or near
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your neck
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o
Patients with an open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s)
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on their neck at the treatment location
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Patients should not use the gammaCore Sapphire CV:
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While they are driving, operating machinery, or during any activity that may put the patient at risk
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of injury
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o
I
f they have any planned surgeries that may involve implants. The patient should advise their
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HCP accordingly
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o
Near microwave machines, magnetic resonance imaging, radio frequency surgical, or computer-
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aided tomography machine
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In an explosive atmosphere or in the presence of flammable gas mixtures
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If the patient has wet skin, is in water, or just stepped out of the water (e.g. shower, bath, pool)
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If the patient is using another device at the same time (e.g. TENS Unit, muscle stimulator) or any
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portable electronic device
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Contact your HCP if your symptoms continue or worsen.
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Warnings indicate instructions, which, if not followed, may result
in serious injury or death to the device user or to the patient.
Precautions indicate instructions, which, if not followed,
may result in damage to the equipment or degradation in the
quality of treatment.